14 results · 21ms · Sources: EU EUDAMED, US FDA

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PULPDENT POST CEMENT

FDA 510(k)
FDA Class 2 ·Dental

MS Sim.LED OpL wSB

FDA UDI
S.I.M.E.O.N. Medical GmbH & Co. KG·04250613849305·

RESTORE ADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 29, 2013

ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 23, 2025

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013

MRH REAM DPTH STP:80MM FEMUR

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code HTJ·February 16, 2011

DEXTRUS 4135

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008

M2A-MAGNUM PF CUP 60ODX54ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 19, 2014

MEDTRONIC IPG

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·February 23, 2026

MICRA AV

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code PNJ·February 23, 2026

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014